HYDROchlorothiazide to PROTECT Polycystic Kidney Disease Patients and Improve Their Quality of Life

ConditionADPKD
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity Medical Center Groningen

About this trial

Autosomal dominant polycystic kidney disease (ADPKD) is characterized by progressive formation of renal cysts which ultimately lead to a loss of renal function.

Tolvaptan (a V2R antagonist) is currently the only effective treatment for preserving renal function in ADPKD. However, side-effects such as polyuria limit its tolerability and thereby the therapeutic potential. This study will test whether co-administration with hydochlorothiazide can improve V2RA efficacy (slowing kidney function decline) and tolerability (quality of life) in ADPKD. Approximately 300 patients will be enrolled.

Eligibility criteria

Qualifiers

ADPKD diagnosis (modified Ravine criteria)

≥18 years old

eGFR > 25 mL/min/1.73m2

On stable treatment with the highest tolerated dose of V2RA for a minimum of 3 months

Disqualifiers

Known intolerance to hydrochlorothiazide

Use of any diuretic

Orthostatic hypotension complaints or blood pressure <105/65mmHg during screening visit

Uncontrolled hypertension (blood pressure >160/100mmHg)

Trial design

Treatments tested in this trial

  • Hydrochlorothiazide 25 mg
  • Placebo

Treatment groups

300 Participants
are divided into 2 treatment groups